title: Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial.
abstract: BACKGROUND
  Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life.
  
  
  METHODS
  A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height(2); circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life.
  
  
  CONCLUSIONS
  CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients.
  
  
  BACKGROUND
  The protocol for this study is registered with the Brazilian Registry of Clinical Trials (ReBEC RBR-7yhr4w and World Health Organization under Universal Trial Number UTN: U1111-1127-9390 [http://www.ensaiosclinicos.gov.br/rg/RBR-7yhr4w/]).
authors.affiliation: Rehabilitation Sciences Master Degree and PhD Program, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil. oliveira.lvf@uninove.br.
authors.forename: Israel
authors.initials: I
authors.lastname: dos Reis Santos
authors.forename: Aline Roberta
authors.initials: AR
authors.lastname: Danaga
authors.forename: Isabella
authors.initials: I
authors.lastname: de Carvalho Aguiar
authors.forename: Ezequiel Fernandes
authors.initials: EF
authors.lastname: Oliveira
authors.forename: Ismael Souza
authors.initials: IS
authors.lastname: Dias
authors.forename: Jessica Julioti
authors.initials: JJ
authors.lastname: Urbano
authors.forename: Aline Almeida
authors.initials: AA
authors.lastname: Martins
authors.forename: Leonardo Macario
authors.initials: LM
authors.lastname: Ferraz
authors.forename: Nina Teixeira
authors.initials: NT
authors.lastname: Fonsêca
authors.forename: Virgilio
authors.initials: V
authors.lastname: Fernandes
authors.forename: Vinicius Alves Thomaz
authors.initials: VA
authors.lastname: Fernandes
authors.forename: Viviane Cristina Delgado
authors.initials: VC
authors.lastname: Lopes
authors.forename: Fernando Sérgio Studart
authors.initials: FS
authors.lastname: Leitão Filho
authors.forename: Sérgio Roberto
authors.initials: SR
authors.lastname: Nacif
authors.forename: Paulo de Tarso Camillo
authors.initials: Pde T
authors.lastname: de Carvalho
authors.forename: Luciana Maria Malosá
authors.initials: LM
authors.lastname: Sampaio
authors.forename: Lílian Christiane
authors.initials: LC
authors.lastname: Giannasi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Romano
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Insalaco
authors.forename: Ana Karina Fachini
authors.initials: AK
authors.lastname: Araujo
authors.forename: Humberto
authors.initials: H
authors.lastname: Dellê
authors.forename: Nadia Karina Guimarães
authors.initials: NK
authors.lastname: Souza
authors.forename: Daniel
authors.initials: D
authors.lastname: Giannella-Neto
authors.forename: Luis Vicente Franco
authors.initials: LV
authors.lastname: Oliveira
mesh_terms: D000293:Adolescent; D000328:Adult; D001007:Anxiety / Q000453:epidemiology / Q000401:mortality / Q000503:physiopathology; D001341:Autonomic Nervous System / Q000503:physiopathology; D001938:Brazil / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000401:mortality* / Q000503:physiopathology; D015897:Comorbidity; D003863:Depression / Q000453:epidemiology* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000401:mortality* / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D017286:Polysomnography / Q000706:statistics & numerical data; D015995:Prevalence; D011446:Prospective Studies; D011788:Quality of Life; D006435:Renal Dialysis / Q000523:psychology*; D012129:Respiratory Function Tests / Q000706:statistics & numerical data; D015656:Respiratory Mechanics; D012307:Risk Factors; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000401:mortality* / Q000503:physiopathology; D013315:Stress, Psychological / Q000453:epidemiology* / Q000503:physiopathology; D015996:Survival Rate; D055815:Young Adult